Device and method of performing cerclage sacrocervicopexy

ABSTRACT

An implantable cerclage sacrocolpopexy medical device includes an elongate strip of flat, flexible material extending longitudinally from a first end to an opposite second end; a surgical needle attached to the first end of the elongate strip; and a loop at either the first end or the second end of the elongate strip. The medical device is positioned circumferentially around the cervix. The end of the elongate strip opposite the end having the loop is passed through the loop and attached to the sacrum or sacrospinous ligament.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority from U.S. Provisional PatentApplication No. 62/709,591 filed on Jan. 23, 2018. This application isalso a continuation-in-part of U.S. patent application Ser. No.15/697,089 filed Sep. 6, 2017, which in turn is a continuation ofInternational Patent Application No. PCT/US2016/021214 filed Mar. 7,2016, which claims the benefit of U.S. provisional application Ser. No.62/177,057 filed Mar. 6, 2015. The entirety of each of theabove-identified applications is hereby incorporated herein byreference.

FIELD

The disclosed subject matter relates to a system for treating pelvicdisorders. Particularly, the present disclosed subject matter isdirected towards a device and method of performing cerclagesacrocervicopexy.

BACKGROUND

A variety of methods and systems are known for treating vaginalprolapse, with sacrocolpopexy being considered by many surgeons to bethe most advantageous treatment of vaginal vault prolapse.Sacrocolpopexy involves suspension of the vagina to the sacrum using anintervening graft material. There are several variations of theprocedure, depending on the patient's anatomy and previous orconcomitant surgery. For example, if the primary problem is uterineprolapse, the surgeon may choose to perform a sacrohysteropexy(attaching the upper posterior vagina and cervix to the sacralpromontory. When combined or following supracervical hysterectomy,sacrocervicopexy is performed, which usually implies use of a “Y”-shapedmesh (similar to sacrocolpopexy), which covers the cervix and extendsover the anterior and posterior vaginal fascia.

In the past, sacrocolpopexy was typically performed through an abdominalincision, although more recently, laparoscopic and roboticsacrocolpopexy techniques have been utilized by pelvic reconstructivesurgeons to reduce the morbidity associated with laparotomy. Variousmaterials have been used in this procedure, including both natural andsynthetic materials, although permanent synthetic mesh is most oftendescribed, due to excellent long-term results described in theliterature. Of the synthetic materials in use today, the most commonlyused is type I, macroporous, monofilament, lightweight polypropylene.This material is well tolerated, easy to handle, and resistant toinfection and erosion through tissues in the pelvis, especially thevagina.

Most surgeons who perform sacrocolpopexy employ a “Y-shaped”configuration of the mesh. This configuration includes two extensions ofthe mesh that provide coverage to the posterior and anterior vaginalwalls. During the surgery, the bladder is advanced off the anteriorvagina and the rectum is dissected free of the posterior vagina byentrance into the rectovaginal septum. The mesh extensions are thenplaced over the anterior and posterior vagina and sutured in place withmultiple interrupted sutures or, more recently, continuous barbedsuture. Once the vaginal sutures have been placed, the surgeon attachesthe mesh to the anterior longitudinal ligament of the sacrum, either atthe promontory or lower, in the hollow of the sacrum. Althoughtraditional suturing of the mesh to the sacrum is commonly used, othersurgeons use a tacking device to fix the mesh to the sacrum. Finally,some surgeons choose to bury the mesh under the peritoneum, to preventthe potential development of internal intestinal hernia and subsequentobstruction.

Support of the apex of the vagina (which may be the cervix in women whohave not had hysterectomy) is an important part of most prolapseoperations and that apical support resolves many cystoceles andrectoceles. Apical support can be assessed in the office setting or inthe operating room, by gently supporting the cervix with an instrument,such as a tenaculum or scopettes. In this manner, the anterior andposterior vaginal walls can be evaluated to determine whether additionalrepair to these compartments is required at the time of reconstructivesurgery. In many instances, support of the cervix alone reduces prolapseof the anterior and/or posterior compartments. In those cases, it may beappropriate to only address cervical support at the time of surgery.

Cervical cerclage refers to one of several surgical procedures in whicha material, such as mesh, tape or suture is used to reinforce thecervix. This is most often performed for women with a history of anincompetent cervix associated with a mid-trimester pregnancy loss.Typically, a pregnant woman with an incompetent cervix will haveexperienced painless dilation of the cervix, resulting in a pregnancyloss. The cerclage is typically performed after 12 weeks gestation in asubsequent pregnancy, after confirming fetal viability. The two mostcommon techniques used are the McDonald and the Shirodkar techniques.Whereas the McDonald technique does not require any surgical dissection,the Shirodkar procedure involves an anterior and posterior incision, inorder to advance the bladder and rectum, respectively, off the cervix.With the Shirodkar technique, the cerclage material may be completelyburied under the vaginal epithelium once the anterior and posteriorincisions are closed at the completion of the procedure. Placement ofthe cerclage material is performed in several tissue bites, stayingmedial to the uterine vessels, which are located bilaterally at the 3:00and 9:00 positions. Once the material has been placed circumferentially,the two ends of the material are usually tied together, eitheranteriorly or posteriorly, and the knot may be placed either under theepithelium or within the vaginal canal, to facilitate removal of thecerclage. The cerclage may be removed late in the pregnancy, although ifa cesarean section is planned, the cerclage may be left in place, andeven used for a subsequent pregnancy.

Many surgeons find that laparoscopic suturing and knot tying are themost time consuming and challenging aspects of sacrocolpopexy and itsvariants. Furthermore, extensive dissection of the bladder and rectumoff the cervix and upper vagina can be difficult for the laparoscopic oropen surgeon, especially in the patient who has previously undergonesurgery in that area (e.g. cesarean section).

There thus remains a need for an effective and efficient method andsystem for performing pelvic disorders with a device(s) that simplifysacrocolpopexy procedures in order to expand the usage of this provenoperation for pelvic organ prolapse.

SUMMARY

The purpose and advantages of the disclosed subject matter will be setforth in and apparent from the description that follows, as well as willbe learned by practice of the disclosed subject matter. Additionaladvantages of the disclosed subject matter will be realized and attainedby the methods and systems particularly pointed out in the writtendescription and claims hereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the disclosed subject matter, as embodied and broadly described, thedisclosed subject matter includes a device for and method of treatingpelvic disorders, including pelvic organ prolapse.

An exemplary implantable cerclage sacrocolpopexy medical device inaccordance with one or more embodiments comprises an elongate strip offlat, flexible material extending longitudinally from a first end to anopposite second end; a surgical needle attached to the first end of theelongate strip; and a loop at either: (1) the first end of the elongatestrip proximate the needle, wherein the loop is sized and shaped toenable passage therethrough of the second end of the elongate stripafter the elongate strip has been positioned to encircle the cervix in acerclage configuration and the needle has been detached from theelongate strip, and wherein the second end of the elongate strip isconfigured for attachment to the sacrum, or (2) the second end of theelongate strip, wherein the loop is sized and shaped to enable passagetherethrough of the first end of the elongate strip after the elongatestrip has been positioned to encircle the cervix in a cerclageconfiguration and the needle has been detached from the elongate strip,and wherein the first end of the elongate strip is configured forattachment to the sacrum.

A exemplary method of treating prolapse in a patient in accordance withone or more embodiments comprises: (a) positioning an implantablecerclage sacrocolpopexy medical device circumferentially around thecervix of the patient, said medical device comprising an elongate stripof flat, flexible material extending longitudinally from a first end toan opposite second end, a surgical needle attached to the first end ofthe elongate strip, and a loop at either the first end or the secondend; (b) detaching the surgical needle from the medical device andremoving the surgical needle from the operative field; (c) passing theend of the elongate strip opposite the end having the loop through theloop; and (d) attaching the end of the elongate strip passed through theloop to the sacrum of the patient.

Devices in accordance with various embodiments include a mesh segmentwith a single needle on one end (either straight or curved, and eithersharp or blunt-tipped) and some form of loop on the other end (or thesame end, as will be described). Once the needle is placedcircumferentially around the cervix (after dissecting the bladder, andpotentially the rectum, off the cervix), the needle is detached andremoved from the operative field. One end of the mesh strip is thenpassed through the loop on the other end of the mesh strip (which hasbeen placed posterior to the cervix) and is then brought up to thedesired location on the anterior ligament of the sacrum and attachedwith some fixation technique (e.g., suture or surgical tacks) afterdetermining the proper tension on the mesh.

Devices in accordance with various embodiments can be used eithertotally “from above” (laparoscopically, robotically, or through anabdominal incision) or in a combination of a vaginal approach (forperformance of the cerclage) with an endoscopic or open approach forattachment of the mesh to the anterior longitudinal ligament of thesacrum. For example, following laparoscopic dissection from the sacrumto the cul-de-sac, the surgeon may change positions to a vaginalapproach. A vaginal incision is made at the anterior cervico-vaginaljunction and the bladder is advanced off the anterior portion of thecervix. A posterior vaginal incision is then made and the posteriorcul-de-sac is entered. The cerclage is then performed and the sacraltail is placed intraperitoneally for subsequent attachment to thesacrum. The anterior and posterior vaginal incisions are then closedwith absorbable suture.

Alternatively, the entire procedure may be performed laparoscopically orrobotically with the same devices described below. After dissection fromthe sacrum to the cul-de-sac, the anterior peritoneum is opened and abladder flap is created, exposing the anterior cervix. The cerclage isthen performed endoscopically, starting posterior to anterior on oneside and then anterior to posterior on the contralateral side. Theneedle may be placed either medial or lateral to the uterine vessels.

It should be understood that whereas each of the figures shows aparticular shaped needle, the needle on each of these embodiments may becurved, straight, or “ski” configuration, and may be either tapered orblunt-tipped. In addition, in any of these configurations, a plasticsheath may cover the area of the mesh or suture that is connected to theswaged needle. This may facilitate passage of the mesh material throughthe cervical tissue.

In some embodiments, one end of the mesh strip is swaged to a straightor curved needle, which is either sharp or blunt-tipped.

In some embodiments, the end of the mesh strip that is swaged on to aneedle has a plastic sleeve covering the area where the mesh is swagedon to the needle, in order to provide less resistance as the mesh isbrought through the cervical tissue

In some embodiments, the needle is swaged on to a suture loop attachedto the end of the mesh strip. The suture loop may also pass through aneyelet on the needle. On the same end of the mesh, there is a second,smaller suture loop, which is either threaded through the end of themesh strip, or ultrasonically welded, or attached to the mesh strip endwith another method of fixation. It is through this second, smaller loopthat the other end of the mesh strip is threaded through before it isbrought up to the desired location on the anterior ligament of thesacrum.

In some embodiments, the other end of the mesh strip (the non-needle endof the strip) has either a loop of permanent suture attached (eitherthreaded through the mesh pores, ultrasonically welded to the mesh, orsome other attachment method), or a folded over end of the mesh tocreate a loop, through which the other end of the mesh is threaded andthen brought up to the sacrum for attachment.

It should be noted that the non-loop end of the mesh in any of theembodiments may be wider than the end of the mesh that has the loop.Therefore, the end of the mesh that will encircle the cervix may be morenarrow and the end of the mesh that will extend and attach to the sacrummay be wider.

In an exemplary embodiment the medical device comprises a base portioncomprising a flexible, flat material and having a length extending fromproximal end and a distal end, and a width extending from a first sideto a laterally opposed second side; at least one arm extending from atleast one of the first or second sides, the at least one arm extending adistance greater than the width of the base portion; wherein the atleast one arm is sized and shaped to be secured around at least aportion of a cervical isthmus.

The flexible, flat material may be mesh, or other flat, flexiblematerials, such as fabric, cross-linked or non-cross-linked biologicgrafts, or combinations thereof. Throughout this disclosure, wherereference is made in this disclosure to “mesh,” it is to be understoodthat other flat, flexible materials may be used. For example, each ofthe various portions of the devices described herein, such as the baseportion, sacral portion, anterior portion, posterior portion, and arm,may be made of mesh or other flat flexible materials.

Additionally or alternatively, in some embodiments the medical devicecomprises a flexible, flat base portion with a length extendinglongitudinally from a proximal end to a distal end, and width extendingfrom a first side to a laterally opposed second side; at least one armextending from at least one of the first or second sides; and whereinthe at least one arm extends a distance greater than the width of thebase portion.

In some embodiments the at least one arm is integrally formed with thebase portion. In some embodiments the at least one arm extends from thefirst side and the base portion includes an aperture disposed proximatethe second side.

In some embodiments the aperture is sized and shaped to receive the atleast one arm irreversibly.

In some embodiments the medical device further comprises a needledisposed at the distal end of the at least one arm.

In some embodiments the medical device further comprises a lockingmechanism, the locking mechanism having an opening to receive a portionof the at least one arm.

In some embodiments the base portion is formed from woven fixed-lengthfibers, and the at least one arm is formed from an elastic material.

In some embodiments the at least one arm is configured as a suture.

In some embodiments the at least one arm includes a plurality ofretention features projecting outward from the at least one arm.

In some embodiments the at least one arm comprises a first arm extendingfrom the first side of the base portion, and a second arm extending fromthe second side of the base portion.

In some embodiments the medical device further comprises a connectordisposed at the distal end of the at least one arm, the connector havingan opening to engage a needle.

In some embodiments an implantable sacrocolpopexy medical devicecomprises: a sacral portion having a length extending from a proximalboundary to a distal boundary, and a width extending from a first sideto a laterally opposed second side; an anterior portion having a lengthextending from a proximal boundary to a distal boundary, and a widthextending from a first side to a laterally opposed second side; aposterior portion having a length extending from a proximal boundary toa distal boundary, and a width extending from a first side to alaterally opposed second side; a first arm extending from the first sideof the posterior portion, the first arm extending a distance greaterthan the width of the posterior portion; and a second arm extending fromthe second side of the posterior portion, the second arm extending adistance greater than the width of the posterior portion.

In some embodiments the anterior portion includes a first eyeletdisposed proximate the first side and a second eyelet disposed proximatethe second side.

In some embodiments the at least one eyelet includes a base having atleast one slot formed therein.

In some embodiments the base includes a plurality of projectionsextending outward from the base surface.

In some embodiments the anterior portion is formed as a separatecomponent from the posterior portion.

In some embodiments the at least one of the first and second armsincludes a needle.

In some embodiments the medical device further comprises a lockingmechanism, the locking mechanism having an opening to receive a portionof at least one of the first and second arms.

In accordance with another aspect of the present disclosure, a method oftreating prolapse comprises: providing an implantable flat, flexiblematerial having at least one arm extending from a side thereof;inserting the at least one arm through cervical tissue to form acervical cerclage; and attaching a portion of the mesh to the sacrum.

In some embodiments the implantable flat, flexible material includes atleast one eyelet.

In some embodiments the method further comprises inserting the at leastone arm through the at least one eyelet.

In some embodiments the insertions are made with a needle disposed atdistal end of the at least one arm.

In some embodiments the insertions are made proximate the cervicalisthmus.

In some embodiments the at least one arm is inserted from a posterior toanterior portion of the cervical isthmus.

In some embodiments an implantable sacrocolpopexy medical devicecomprises an elongate base portion having a length extendinglongitudinally from a proximal end to a distal end; a sleeve disposedaround at least a portion of the distal end of the base portion; adilator disposed at a distal end of the sleeve; and a needle disposed ata distal end of the dilator.

In some embodiments the medical device further comprises a suturedisposed between the dilator and the needle.

In some embodiments the medical device further comprises at least onesuture loop attaching the dilator to the base portion.

In some embodiments the needle has a curved geometry.

In some embodiments a proximal end of the base portion includes aneyelet.

In some embodiments the medical device further comprises a lockingmechanism, the locking mechanism having an opening to receive a portionof the elongate base portion.

In some embodiments a proximal end of the base portion has a largersurface area than a distal end of the base portion.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and are intended toprovide further explanation of the disclosed subject matter claimed.

The accompanying drawings, which are incorporated in and constitute partof this specification, are included to illustrate and provide a furtherunderstanding of the method and system of the disclosed subject matter.Together with the description, the drawings serve to explain theprinciples of the disclosed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of various aspects, features, and embodiments ofthe subject matter described herein is provided with reference to theaccompanying drawings, which are briefly described below. The drawingsare illustrative and are not necessarily drawn to scale, with somecomponents and features being exaggerated for clarity. The drawingsillustrate various aspects and features of the present subject matterand may illustrate one or more embodiment(s) or example(s) of thepresent subject matter in whole or in part.

FIGS. 1-4 are schematic representations of exemplary embodiments of themedical device with a single mesh cerclage material arm in accordancewith the disclosed subject matter.

FIGS. 5 and 7 are schematic representations of exemplary embodiments ofthe medical device with a plurality of mesh cerclage material arms inaccordance with the disclosed subject matter.

FIGS. 6 and 8 are schematic representations of exemplary embodiments ofthe medical device with a plurality of mesh cerclage material arms andneedles in accordance with the disclosed subject matter.

FIGS. 9, 10 and 12 are schematic representations of exemplaryembodiments of the medical device with a plurality of mesh cerclagematerial arms, and anterior mesh extension, in accordance with thedisclosed subject matter.

FIGS. 11 and 13 are schematic representations of exemplary embodimentsof the medical device with a plurality of mesh cerclage material arms,anterior mesh and posterior mesh extensions, in accordance with thedisclosed subject matter.

FIGS. 14 and 15 are schematic representations of exemplary embodimentsof the method of operating the medical device, in accordance with thedisclosed subject matter.

FIG. 16 is a schematic representation of exemplary embodiment of themedical device with a base portion, sleeve, dilator and needle, inaccordance with the disclosed subject matter.

FIGS. 17-19 are schematic representations of exemplary embodiments of aneyelet which can be incorporated with the medical device, in accordancewith the disclosed subject matter.

FIG. 20 is a schematic representation of an exemplary embodiment of themedical device with a plurality of mesh cerclage material arms coupledtogether, in accordance with the disclosed subject matter.

FIGS. 21-23 depict clip connectors suitable for affixing mesh to mesh.

FIG. 24 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle attached to one end of a mesh stripwith a loop at the other end, created by folding over the end of themesh and fixating it to itself, with suture, ultrasonic welding, or someother method of attachment of mesh to mesh.

FIG. 25 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle attached to one end of a mesh stripwith a more narrow loop at the other end, created by folding over a morenarrow portion of the end of the mesh and fixating it to itself, withsuture, ultrasonic welding, or some other method of attachment of meshto mesh.

FIG. 26 illustrates an exemplary medical device in accordance with oneor more embodiments having needle attached to one end of a mesh stripwith a loop at the other end, created by a permanent suture attached tothe end of the mesh. This may be a permanent suture material, such aspolypropylene, and may be ultrasonically welded to the end of the mesh,or may be threaded through the end of the mesh and suture as a loop.

FIG. 27 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle swaged on to a loop of suturematerial, which is attached to the end of a mesh segment by eitherthreading it through the mesh, ultrasonically welding it to the mesh, orsome other mechanism of attachment. There is a second permanent sutureloop on the same end of the mesh, which is also attached to the mesh bythreading it through the mesh, ultrasonically welding it to the mesh, orsome other mechanism of attachment. Once the cerclage is complete, thesuture swaged on to the needle is cut, leaving the other loop attached,and the other end of the mesh strip is brought through the loop and thenattached to the sacrum, after determining the proper tension.

FIG. 28 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle swaged on to a suture loop, which isinterlocked with another suture loop made of permanent suture, which iseither threaded through, ultrasonically welded, or otherwise attached tothe end of the mesh strip. Once the cerclage is complete, the sutureswaged on to the needle is cut, leaving the other loop attached, and theother end of the mesh strip is brought through the loop and thenattached to the sacrum, after determining the proper tension.

FIG. 29 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle swaged on to a suture loop, which isinterlocked with another suture loop made of permanent suture, which iseither threaded through, ultrasonically welded, or otherwise attached tothe narrow end of the mesh strip, which may come in various lengths. Thenarrow mesh strip may then transition to a wider mesh strip for theremainder of the length of the mesh strip. Once the cerclage iscomplete, the suture swaged on to the needle is cut, leaving the otherloop attached, and the wider end of the mesh strip is brought throughthe loop and then attached to the sacrum, after determining the propertension.

FIG. 30 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle swaged on to a narrow mesh strip,which is then attached to a loop of the mesh strip, which is thenattached to another thin strip of mesh, which may come in variouslengths. The narrow mesh strip may then transition to a wider mesh stripfor the remainder of the length of the mesh strip. Once the cerclage iscomplete, the thin mesh strip swaged on to the needle is cut, leavingthe mesh loop attached, and the wider end of the mesh strip is broughtthrough the mesh loop and then attached to the sacrum, after determiningthe proper tension.

FIG. 31 demonstrates the position of an exemplary device in accordancewith one or more embodiments after placement around the cervix as acerclage with one end of the mesh strip having a loop on the end, andthe other end of the mesh strip passing through the loop and thenattached to the sacral promontory.

DETAILED DESCRIPTION

The present disclosure describes a novel device and method for treatingpelvic disorders, which in an exemplary embodiment, includes mesh designfor apical support for the condition of uterovaginal prolapse. Inaccordance with another aspect of the present disclosure, a novel methodis provided for performing the device in a completely transvaginaltechnique. Some exemplary embodiments are particularly suited to treatuterine prolapse while others are particularly suited for treatment ofvaginal prolapse as they can include anterior or posterior extensions ofthe mesh.

In some embodiments, the device may comprise two components: a materialthat is used to create a cervical cerclage (or other type of attachmentto the cervix), and an attached sacral extension. Additionally oralternatively, there may be a third component, which is an anteriorand/or posterior extension when the surgeon wants additional coverage inthose areas. The cerclage material may be suture, barbed suture, amolded material in a fishbone or other design that prevents slippage ofthe material back through the tissue, or may be a mesh material that hasinherent self-adherence properties (for example, polypropylene orpolyester mesh, similar to the TVT—tension-free vaginal tape—sling). Atthe end of the cerclage arm there may be a curved, straight, “ski” orother type of needle, which may be sharp or blunt-tipped to drive thecerclage material through the cervical tissue. The cerclage arm may havea plastic sleeve that assists with passage of the cerclage through thetissue (by reducing friction of the cerclage material against thecervical tissue), which can later be removed, leaving the cerclagematerial in place. The needle may be attached to some material (such asa polymer) that acts as a tapered dilator of the tissue, to transitionfrom a needle to the cerclage (especially if the cerclage is a mesh) toassist with getting the material through the tissue.

In use the surgeon may perform the cerclage using a needle driver orother laparoscopic or open instrument, and may do this in as little astwo bites (e.g. posterior to anterior and back from anterior toposterior), but this may also be done in multiple, smaller tissuepurchases. In one exemplary technique, the surgeon would begin thecerclage posteriorly and would take successive tissue purchases toencircle the cervix, which may require passing the cerclage materialmedial to the uterine arteries on either side of the cervix (preferablyat the level of the cervical isthmus). The cerclage would be completedposteriorly on the other side of the cervix and the surgeon may pass thecerclage material (still attached to the needle) through some mechanismon the mesh (e.g. an aperture, such as an eyelet) so that it completesthe cerclage and can be cinched down without the need for tying a knotin the cerclage material. The cerclage material can then be trimmed soexcess material is not sticking out from the eyelet on the mesh. Oncethis is complete, the sacral extension can be attached in traditionalmethods to the sacral promontory (anterior longitudinal ligament) orother apical supporting structure, such as the sacrospinous ligament.For example, the surgeon may use sutures or a tacking device to attachthe sacral extension to the sacrum or sacrospinous ligament. It shouldbe noted that the cerclage procedure may be performed eitherendoscopically (laparoscopic or robotic) or may be performedtransvaginally.

If performed vaginally, the surgeon would make an incision anteriorlybetween the cervix and the proximal anterior vaginal wall, and woulddissect the bladder off the anterior portion of the cervix, far enoughto permit the cerclage material to lay flat on the cervix. An incisionwould also be made posteriorly and the rectum dissected off theposterior portion of the cervix, to allow the mesh to lay down flatagainst the cervix. An incision is also made in the peritoneum in theposterior cul-de-sac. The cerclage is then performed using a techniquesimilar to the Shirodkar cerclage, keeping the cerclage material underthe vaginal epithelium. After the cerclage is completed, the two ends ofthe cerclage material are exiting the cervical tissue posteriorly, andonce the connection is made between the free end and the base of themesh (part of the sacral extension), the sacral extension is placedthrough the incision in the cul-de-sac and into the pelvic cavity.Subsequent to this, the vaginal epithelial incisions are closedanteriorly and posteriorly and the remainder of the procedure can beperformed abdominally (including laparoscopically or robotically).Alternatively, an instrument may be placed through a cannula placedtransvaginally in the posterior cul-de-sac in order to introduce suturesand/or needles into the pelvic cavity or to fix the mesh to the sacrumdirectly using an instrument such as a tacking device.

Another vaginal technique that can be used is to place the cerclage in amanner similar to a Shirodkar procedure (as described previously), withthe mid-portion of the mesh or fabric strip located on the anteriorportion of the cervix and bringing the two ends of the mesh from theanterior to the posterior portion of the cervix with the use of needles(straight, curved, ski, or other) attached to the mesh, or with the useof an instrument, such as an Emmet-type needle with an eyelet, throughwhich the ends of the mesh can be threated to facilitate transferthrough the lateral cervical stroma. The two ends of the mesh arms,which exit posteriorly in the cervix, may be attached to one another tocreate a mesh extension that is twice the width of the mesh arm usingone of several methods, such as interrupted sutures, a continuoussuture, or hook-and-loop fasteners to unite the two edges, heat sealingor other method of attaching the two ends of the mesh. Attachmentfeatures integral to one or both arms may impede passage through thecervix, so one or both arms may be provided in removable sleeves, suchas plastic sleeves, to facilitate passage. This wider mesh extensionwould then be placed into the posterior cul-de-sac and eventuallyattached to the sacrum (anterior longitudinal ligament), as is commonlydone with a traditional sacrocolpopexy. In another embodiment, themid-portion of the mesh strip is more narrow (approximately 1.5 cm wide)than the ends of the mesh strip (approximately 2 cm wide). Themid-portion of the mesh strip may be approximately 12 cm long so thatthe more narrow portion of the mesh can completely encircle the cervixwith the cerclage technique, whereas the ends are wider, so the ends canbe united to form a sacral attachment piece that is approximately 4 cmwide. In order to facilitate movement of the wider portion of the meshthrough the cervix during the cerclage, the needle on each end of themesh may have a molded piece between the needle and the mesh, which istapered to permit smooth transfer of the mesh through the cervicaltissue. The molded piece may attach to the end of the mesh strip in sucha way as to fold the mesh strip in half so that for instance, ratherthan a 2 cm wide mesh, the mesh is folded over to become only 1 cm wide.The molded piece may be attached to a plastic sleeve that covers thewider portion of the mesh to facilitate transfer of the mesh through thecervix. This plastic would also function to help keep the mesh foldedover.

In some embodiments the cerclage material may have two arms extendingfrom either side of the sacral mesh extension. On the ends of either armmay be needles that may be driven from posterior to anterior cervix(preferably at the level of the cervical isthmus). Once the needles andattached cerclage material have been drawn to the anterior portion, thematerial (e.g. mesh, barbed suture) may be cut at the level of thecervix so that the material does not extend out from the cervicalsurface. A locking mechanism, such as a small plastic disc, may beplaced over the arm material and placed flush up against the anteriorcervix and act to prevent slippage of the arm back through the cervicaltissue. Alternatively, the ends of the cerclage arms may have connectorsattached. A needle device inserted through a laparoscopic or roboticcannula, or placed percutaneously through the abdomen (or directly, inthe case of open surgery), or placed through a portion of the cervixwhen performed transvaginally may perforate the cervix from anterior toposterior, and then make a connection with the connector attached to thecerclage arm (e.g. ferule) and when withdrawn, pulls the mesh armthrough the cervix, which may then be cut at the anterior surface of thecervix. Again, a plastic disc may be utilized to lock the mesh armagainst the anterior cervical surface. These mesh arms may have acovering plastic sleeve, which would allow easier passage of the armthrough the cervical tissue and would be removed once the material is inproper position, thus engaging the material within the tissue.

In some embodiments, for women after supracervical hysterectomy (eitherremote from surgery or when performed concomitantly), the device mayhave an anterior extension which is long enough to reach the anteriorportion of the cervix, and potentially down further along the anteriorvaginal wall, with one or more holes on either side. These holes may bereinforced (to prevent tearing) or may have eyelets, possibly with amechanism that allows passage of the posterior mesh arm through withoutthe ability of the mesh arm to back out from the eyelet.

The posterior extension may extend to the posterior surface of thecervix (or further to cover the posterior vaginal wall), and may thenhave two mesh arm extensions, suture, barbed suture, or a monofilamentpolymer in a fishbone configuration which may have needles or ferulesattached at the distal ends. If mesh arms are employed, the mesh armsmay have plastic sleeves covering the arms to facilitate passage of themesh arms through the tissue. If a needle is employed at the ends of thearms, the needle would be driven from posterior to anterior cervix, andthen would be placed through the holes/eyelets on the anterior meshsegment. The arms would be cut after passage though the anterior meshsegment.

A locking mechanism may be placed over the arms once they pass throughthe anterior mesh segment to prevent slippage back through the tissue.If a ferule is employed at the ends of the arms, a needle may be placedfrom anterior to posterior cervix, first passing through the anteriormesh segment hole/eyelet, then through the cervix, and then engage theferule and withdraw the arm material through the cervix and up throughthe anterior mesh segment. A locking mechanism (which may have beenpreloaded on the needle) may then be cinched over the arm, locking it inplace and preventing backing of the arm through the cervix. Once thecervix has been secured bilaterally, the sacral mesh segment would befixed to the sacrum in standard fashion, as previously described.

In some embodiments, a similar design as described above forsupracervical hysterectomy could have an anterior extension with eyeletsin the proximal anterior extension, but could have a longer anteriorsegment, which could cover some part of the anterior vaginal wall and besutured to the anterior vaginal wall. Similarly, there may be aposterior mesh extension that could cover some part of the posteriorvaginal wall and be sutured thereto.

In some embodiments, whether or not a supracervical hysterectomy hasbeen performed, a separate anterior mesh segment with eyelets may beincluded in the system. The mesh arms that are brought from posterior toanterior (either as a cerclage or directly from posterior to anterior asdescribed earlier) can be passed through the eyelets of the anteriormesh segment (with or without an additional locking mechanism) and thenthe rest of the anterior mesh segment may be sutured to the anteriorvagina and lower aspect of the cervix using traditional laparoscopicsuturing.

The cerclage may be performed transvaginally in the following manner. Atenaculum or other grasping instrument may be placed on the cervix andan incision is made on the anterior cervical vaginal junction. Thebladder is advanced off the cervix and lower uterine segment, as is doneduring the first stage of a vaginal hysterectomy. A posterior incisionmay also be made and at some point, and entry into the posteriorcul-de-sac is made. Alternatively, a complete circumferential incisionmay be made around the cervix to advance the vaginal epithelium off thecervix. The needle attached to the narrow cerclage mesh is used tocreate a cerclage into the cervix. For example, a purchase may be madeposteriorly, and then laterally, avoiding the uterine arteries by goinginto the stroma of the cervix. One or more tissue bites would then betaken anteriorly and then on the opposite lateral side of the cervix.Finally, the needle would be passed through the hole or grommet on thebody of the mesh. Alternatively, there may be some device on the base ofthe mesh that locks the cerclage in place. Alternatively, the mesh stripmay be sutured to the base of the mesh with permanent or delayedabsorbable sutures. At this point, the needle and excess mesh would beremoved from the device leaving the sacral tail extension.

In some embodiments with two cerclage arms, each with needles on theends, purchases of the cervix could be made laterally from posterior toanterior and then into the anterior cervix; these could occur atslightly different levels on the anterior cervix so that the mesh armsdo not intersect with one another and may overlap. The arms would stayin place by friction between the mesh arms and the cervical tissue.Alternatively, the mesh arms may overlap on the anterior cervix and besutured together in that location, potentially with a permanent ordelayed absorbable suture.

In some embodiments, the system comprises straight piece of sling-likemesh with one end attached to a curved needle, possibly with aprotective plastic sleeve, leading to a plastic dilator, which isattached to a curved needle, such as CT2 or CT1. On the other end of themesh device is a reinforced grommet, possibly with a narrow slit to lockthe mesh in place. Other locking mechanisms may also be used. When theneedle and mesh are placed through the cervix in a cerclage-fashion, theneedle is placed back through the center of the grommet, the cerclage istightened and the needle and plastic sleeve is removed from the rest ofthe mesh. The tail of the mesh is placed into the pelvic cavity and, ifthe case is to be completed laparoscopically or robotically, the vaginalincision is closed. If the case is to be completed vaginally, theprocedure proceeds either endoscopically or purely vaginally.

For embodiments employing the endoscopic technique, a trocar cannulawould then be placed up through the anterior or posterior incision intothe cul-de-sac. This cannula may have a balloon or foam tip, or othermechanism, that maintains pneumoperitoneum. The pelvic cavity would thenbe insufflated, enabling the surgeon to view the right pelvic sidewalland sacral promontory. At this point, the surgeon would have severalalternative options. First, a small incision could be made on the rightpelvic sidewall and a blunt instrument could be used to dilate a tunnelup to the sacral promontory while observing this endoscopically throughthe transvaginal cannula. Both the blunt instrument and the laparoscopemay be placed through a single port in the cul-de-sac. The sacral tailcould then be placed with a grasper into the tunnel and up to the sacrumand the some fixation device, such as a spiral tacker maybe used to fixthe sacral tail to the sacrum. Alternatively, after determining theproper tension on the mesh, the spiral tacker could be used to pick upthe proper length of the sacral tail (by partially deploying the tack)and bring the mesh arm up to the sacrum, where it would be attached.

Alternatively, the tip of the cannula could be placed into this incisionand insufflation of the retroperitoneum could be performed. This wouldallow the tacking to be performed under direct visualization, ratherthan indirectly through the peritoneum.

Alternatively, under direct visualization, an incision could be madealong the right pelvic sidewall up to the sacral promontory. Afterattaching the mesh to the sacrum using either a spiral tacking device orsuture, or other device, the peritoneum could be closed over the mesh inone of several ways, including surgical staples or clips that are placedalong with the laparoscope through the transvaginal port, as insingle-port surgery.

Alternatively, once the vaginal cerclage is placed, the surgeon couldplace the sacral tail into the abdominal cavity, and then proceedlaparoscopically or robotically with fixation of the sacral tail to thesacral promontory. This may involve opening up the right pelvic sidewalland peritoneum over the sacral promontory. If the surgeon were to use avaginal trocar as described earlier, a fixation device such as a spiraltacker could be placed transvaginally with laparoscopic guidance, whichmay provide a more anatomic approach to correct sacral fixation. If someinstances, the sutures may be tied intracorporeally or extracorporeallyeither through the transvaginal cannula or through one of thelaparoscopic cannulas. The peritoneum may then be closed over the meshby inserting the suture and needle through the transvaginal cannula.

Thus, in accordance with an aspect of the present disclosure, a systemis provided for performing sacrohysteropexy or sacrocervicopexy, whichcan be performed open, laparoscopically or robotically. In someembodiments, the system has at least two components: a material andneedle for performing a cervical cerclage (or passage through thecervical tissue); and a sacral mesh extension. The device can beemployed to treat uterine prolapse, by supporting the apex of the vagina(i.e. cervix) by encircling the cervix with a cerclage material or bypassing the material through the cervix, and then attaching the cerclageto the sacral area with the use of an intervening mesh extension. Thisprocedure can be performed with or without supracervical hysterectomy,but does require that the cervix, or at least some portion of thecervix, be present, in order to perform the cerclage. Performing thecerclage at the isthmus of the cervix (the cervico-uterine junction)serves to reduce, or eliminate, the risk of erosion/exposure of thecerclage into the vagina. The surgery may involve dissection of thebladder off the lower cervical segment, although in some women, nodissection may be necessary if the bladder is found not to be adherentto the upper cervix. After introduction of the device into the pelviccavity (and dissection of surgical spaces as needed), the surgeon mayperform a cerclage with the cerclage material.

The cerclage material may be comprised of mesh, suture, barbed suture, amaterial with a fishbone configuration, or other material that mayprevent the cerclage from backing out through the cervical tissue. Aneyelet in the body of the mesh may assist with stabilization of thecerclage. The cerclage material can be attached to the sacral meshextension, which could then be attached to the sacrum (e.g. anteriorlongitudinal ligament of the sacrum) in one of several methods, such assuturing or tacking.

In another embodiment, there may be two arms extending from either sideof the sacral mesh extension. These two arms may be constructed of mesh,suture, barbed suture, a material with a fishbone configuration, orother material that may prevent the material from backing out throughthe cervical tissue.

The two arms may have attached needles, each of which may be drawnthrough the cervical tissue, or alternatively, the two arms may haveconnectors (ferules) attached. The surgeon would then have to pass aneedle (such as a straight needle) either through a laparoscopic orrobotic cannula, or percutaneously through the abdomen, or directlythrough an abdominal incision, which would pass through the cervix, onone of both sides, and make a connection with the ferule connectors, andthen withdrawal of the needle would pull the arms through the cervicaltissue. The arms could then be cut at the level of the cervix.

Exemplary Illustrated Embodiments

Reference will now be made in detail to exemplary embodiments of thedisclosed subject matter, examples of which are illustrated in theaccompanying drawings. The method and corresponding steps of thedisclosed subject matter will be described in conjunction with thedetailed description of the system.

In accordance with an aspect of the present disclosure, the devicegenerally includes a base portion having a length extending fromproximal end and a distal end, and a width extending from a first sideto a laterally opposed second side. The base portion can be formed withone or more bulbous projections at the distal end, to form a Y-shapebase portion. An arm extends from a side of the base portion, andproximate the distal end of the base portion, a distance greater thanthe width of the base portion. The length of the arm can vary toaccommodate different patient anatomies, but is sized and shaped so thatit can be configured to extend around the cervical isthmus in anundulating fashion to form a cerclage. In some embodiments, the arm hasa length that is sufficient to be configured into an annular bandsurrounding the entire perimeter of the cervical isthmus. In someembodiments the arm has a length that is sufficient to extend along onlya single side of the cervical isthmus. In some embodiments the baseportion and arm are formed as separate components, which can be madefrom homogenous or distinct materials. For instance, the base portioncan be formed of woven fixed-length fibers, and the arm can be formed ofa material with greater elasticity than the base portion. In suchembodiments the arm can be coupled to an edge of the base portion. Inother embodiments the base portion and arm are integrally formed as aunitary member. In some embodiments the base portion can be providedwith sufficient length so that the proximal end can be attached to thesacrum or other apical structure. In some embodiments the base portioncan include a discrete sacral mesh extension.

As mentioned above, the materials used to make the various portions mayhave a variety of elasticities. For example, the portion that forms thecerclage may be relatively inelastic in the longitudinal axis of thecerclage. The portion that extends to the sacrum similarly may beinelastic in the longitudinal axis toward the sacrum. A material such asmesh is made inelastic in a particular direction by orienting the fibersorthogonal to the direction of desired inelasticity, i.e., fibersarranged in a rectangular or square pattern with the sides orientedparallel and perpendicular to the direction of desired inelasticity.This type of material can be made elastic by orienting the fibers at anangle transverse to the direction of desired elasticity, such as a45-degree angle, such as in a diamond pattern.

As shown in FIG. 1, the base portion (4), which is configured forattachment to, e.g., a sacrum, includes a mesh arm (1), which serves asthe cerclage material for attachment to the cervical isthmus. The arm(1) can include a needle (2) on the distal end which assists in thepiercing of tissue when performing the cerclage around the cervicalisthmus, or portion thereof. Additionally, the base portion can includean eyelet (3) located near a side opposite of the arm (1), and at thedistal end of the base portion. The arm (and needle if present) can beadvanced through the tissue to form a cerclage and received through theeyelet (3). The mesh arm (1) can be formed with a tapered shape, asshown, so that frictional forces are increased as the mesh arm isinserted through the eyelet (3). The eyelets disclosed herein can bereinforced to increase the strength and elasticity by providingadditional (localized) layers of material around the opening, or bycoupling a separate ring of bio-compatible material around the opening.The exemplary embodiment shown can be integrally formed as a unitarymember in which the base portion (4) and arm (1) are a single piece.Alternatively, the base portion (4) and arm are formed as separatecomponents. Additionally, the base portion (4) can itself be formed astwo discrete components, one forming a Y-shaped member and the otherforming a sacral extension.

FIG. 2 depicts another exemplary embodiment in which the arm is formedas a suture cerclage (5). The suture cerclage arm can include a needle(2) on the distal end, and an eyelet (3) on the body of the baseportion. Additionally, a locking mechanism (6) can be coupled to the endof the suture cerclage arm (5) after it is passed through the eyelet(3). The locking mechanism may be made of a material, such as titanium,that can be crimped around the suture with the use of a grasping orclamping device. In some embodiments a permanent lock can be included toprevent slippage of the suture back through the eyelet. The lockingmechanism can be sized with an aperture to receive a portion of thesuture cerclage arm (5), and/or needle (2) if present, to ensure thatthe suture does not pull back through the cervical tissue.

FIG. 3 depicts another exemplary embodiment, wherein the arm includesretention features, e.g., barbs projecting outward from the arm. Thebarbs can project in a uniform, or non-uniform (e.g. at a variety ofdifferent angles with respect to the arm), and at varying lengths as sodesired. As such, the arm is configured as a barbed suture cerclage (7).Additionally, and as previously described, a needle (2) can be includedon the end of the barbed suture cerclage (7), and an eyelet (3) can beincluded on the body of the base portion (4). Also, and as previouslydescribed, a locking mechanism (6) can be added to the end of the sutureafter passing through the eyelet (3), to ensure that the suture does notpull back through the cervical tissue.

FIG. 4 depicts another exemplary embodiment, wherein the arm includesretention features, e.g. a fishbone-shaped projection. The fishboneprojections can each be oriented in the same direction with respect tothe arm, lie within the same plane, and have a uniform length. As such,the arm is configured as a monofilament cerclage device (8).Additionally, and as previously described, a needle (2) can be includedon the end of the monofilament cerclage (8), and an eyelet (3) can beincluded on the body of the base portion (4). Also, and as previouslydescribed, a locking mechanism (6) can be added to the end of the sutureafter passing through the eyelet, to ensure that the cerclage materialdoes not pull back through the cervical tissue.

FIG. 5 depicts another exemplary embodiment, wherein two mesh cerclagearms (1) are provided, each extending outward from a side of the baseportion (4). Additionally, and as previously described, a needle (2) canbe attached to the ends of the arms (1). During operation, the arms (1)can be driven from posterior to anterior cervix on either side of thecervix, and then the mesh may be cut at the anterior surface of thecervix.

FIG. 6 depicts another exemplary embodiment, wherein the two mesh arms(1), include a plastic or metallic connector (e.g. plastic or metallicferule) (9) attached at the distal ends. The needle device may have oneor more concentric rings that engage within the plastic or metallicferule so that an irreversible attachment is made between the needle andthe ferule, enabling the mesh arms to be drawn up along with the needle.Exemplary arrangements of needles and ferrules are shown in FIGS. 4,10a-c, and 13 of U.S. Pat. No. 6,612,977, the cited portions of whichare hereby incorporated herein by reference. During operation, a needledevice (10) is driven through an eyelet on the anterior mesh extension,and then from anterior cervix to posterior cervix on either side of thecervix, which then makes a connection with the connector (9) and drawsthe mesh arm up through the cervical tissue, through the eyelet (3), andthen the mesh may be cut at the anterior surface of the cervix. Forexample, in some embodiments the sacral mesh extension may beapproximately 12 cm in length, and the anterior mesh extension, can beapproximately 4 cm in length.

FIG. 7 depicts another exemplary embodiment, wherein two arms (7) areprovided with retention features (e.g. barbs or fishbone elements) sothat the arms are configured as barbed or fishbone monofilament arms(7). Additionally, and as previously described, a needle (2) can beattached to the distal ends of the arms (7) which can be driven fromposterior to anterior cervix on either side of the cervix, and then thearms may be cut at the anterior surface of the cervix.

FIG. 8 depicts another exemplary embodiment, wherein two arms (7) areprovided with retention features (e.g. barbs or fishbone elements) sothat the arms are configured as barbed or fishbone monofilament arms(7). Additionally, and as previously described, the arms (7) can each beattached to a connector (9). A needle device (10) is driven fromanterior cervix to posterior cervix on either side of the cervix, whichthen makes a connection with the connector (9) and draws the arm (7) upthrough the cervical tissue, and then the arms may be cut at theanterior surface of the cervix.

FIG. 9 depicts another exemplary embodiment, wherein the base portion,which serves as a sacral portion (4) to be attached to the sacrum,includes an anterior portion (or extension) (11). The anterior meshextension (11) can be formed as a separate element from the sacralportion (4), and made of different material. Alternatively, the sacralportion (4) and anterior mesh extension (11) can be integrally formed asa unitary member. The sacral portion (4) can be formed with a length andwidth that is substantially equivalent to a length and width of theanterior mesh extension (11). If formed separately, the distal edge ofthe sacral portion (4) can be coupled to the proximal edge of theanterior mesh extension (11). As shown, two arms (1) are provided withdistal needles (2) and extend from the sides of the anterior portion(11). Alternatively, the arms (1) can extend from the sides of thesacral portion (4). Additionally or alternatively, the arms (1) can beformed as a separate portion from the sacral mesh portion (4) andanterior portion (11) such that the arms (1) serve a posterior portionthat extends a shorter length than the sacral mesh portion (4) andanterior portion (11). As previously described, the anterior meshextension (11) can include two or more eyelets (3), through which themesh arms (1) are placed and a locking mechanism (6) may be used to helpaffix the arms to the anterior mesh segment.

FIG. 10 depicts another exemplary embodiment, similar to the embodimentdescribed in FIG. 9, wherein an anterior portion (or extension) (11) isemployed which is particularly suited for use after supracervicalhysterectomy, in which the surgeon elects to extend the anterior meshextension (11). In this embodiment, the proximal anterior mesh extension(11) may have two mesh arms (1) with needles (2) extending from thesides thereof. Alternatively, the arms (1) can extend from the sides ofthe sacral portion (4). The mesh arms (1) may be placed in a cerclagefashion from anterior to posterior cervix, or may be brought directlythrough the cervix from posterior to anterior cervix, and then the mesharms (1) may pass through eyelets (3) on the anterior mesh extension(11). The anterior mesh extension (11) may extend to cover more of theanterior vaginal wall. It is noted that the location of the eyelets (3)can vary as desired and depending on the particular cerclage techniqueemployed by the physician. As shown in FIG. 9, the eyelets (3) can belocated at a distal end of the anterior mesh extension (11). Conversely,and as shown in FIG. 10, the eyelets (3) can be located closer to theproximal edge of the anterior mesh extension (11).

FIG. 11 depicts another exemplary embodiment, similar to the embodimentdescribed in FIG. 10 above, further including a posterior portion (orextension) (12) that may extend over more of the posterior vaginal wall.In some embodiments, the sacral portion (4), anterior portion (11) andposterior portion (12) are configured with substantially equivalentlength and widths. As shown, the arms (1) extend from the sides of theposterior portion (12). Alternatively, the arms (1) can extend from thesides of the sacral portion (4), or sides of the anterior portion (11).

FIG. 12 depicts another exemplary embodiment, which may be used with orwithout supracervical hysterectomy. Similar to the embodiments describedin connection with FIGS. 9-11, a sacral portion (4) has two mesh arms(1) with needles (2), which may be placed from posterior to anteriorcervix either in a cerclage fashion or directly from posterior toanterior cervix. Additionally, an anterior portion (or extension) (13)is formed as a separate segment with eyelets (3) and is placedanteriorly. A proximal edge of the anterior portion (13) can be coupledto the distal edge of the sacral portion (4), or directly to the arms(1), as shown. The mesh arms (1) are brought up through the proximaleyelets (3) on the anterior portion (13) and are either self-locking, oradditional locking devices (6) may be placed over the mesh arms (1). Inoperation, the anterior portion (13) may be sutured into position on theanterior vaginal wall after the bladder is dissected off the anteriorvagina.

FIG. 13 depicts another exemplary embodiment which may also be used withor without supracervical hysterectomy. Similar to the embodimentdescribed in connection with FIG. 12, a posterior portion (12) has twomesh arms (1) extending from its sides with needles (2), which may beplaced from posterior to anterior cervix either in a cerclage fashion ordirectly from posterior to anterior cervix. Alternatively, the arms (1)can extend from the sides of the sacral portion (4), or sides of theanterior portion (11). A separate base portion (13) with eyelets (3) isplaced anteriorly. The arms (1) of the posterior portion (12) arebrought up through the proximal eyelets (3) on the anterior portion (13)and are either self-locking, or additional locking devices (6) may beplaced over the mesh arms (1). The anterior portion (13) may be suturedinto position on the anterior vaginal wall after the bladder isdissected off the anterior vagina. The posterior portion (12) may havean attached posterior portion (12) that extends down the posteriorvaginal wall.

FIG. 14 depicts the operation of the device as described in connectionwith FIG. 5, with the cerclage arms (1) having been placed from theposterior to the anterior portion of the cervical isthmus (14) and thesacral mesh segment (4) attached to the sacral promontory (15).

FIG. 15 depicts the operation of the device as described in connectionwith FIG. 9, with the cerclage arms (1) having been placed from theposterior to the anterior portion of the cervical isthmus (14) and thenup through the eyelets (3) on the anterior mesh extension (11). Thesacral portion (4) would extend up to the sacral promontory.

FIG. 16 depicts another exemplary embodiment in which an elongated mesh(1) is provided with a curved needle (2) at a distal end. The radius ofcurvature of the needle can be selected dependent upon the particularpatient anatomy. The needle (2) can be attached to a monofilament ormultifilament suture (16), which may either be absorbable ornon-absorbable, which is attached to a plastic dilator (17), which isattached to a plastic sleeve (18), with one or more suture loops (19)holding the mesh to the plastic dilator. The suture loops, which may bemade from a monofilament suture, pass through the interstices of themesh to prevent the mesh from slipping out of the plastic sheath. On theother (proximal) end of the mesh is a grommet or eyelet (3). The eyelet,which can include reinforced material as described above, receives theneedle after the cerclage has been performed. The eyelet (3) can beformed with a non-uniform geometry with a distal portion of the eyelethaving a larger and generally circular opening, while a more distalportion of the eyelet is formed with a more narrow, and linear slot.Additionally, the eyelet (3) may have a mechanism that assists inlocking the mesh in place to prevent it from slipping back through theeyelet. For instance, the proximal end of the mesh strip (1), which isto be attached to the sacrum or other apical structure, such as thesacrospinous ligament, may be wider than the portion of the strip ofmesh (1) that is used as a cerclage. Such a configuration isadvantageous in that it provides a larger surface area for attachment ofthe mesh to the sacrum or other apical structure, such as thesacrospinous ligament.

FIG. 17 depicts an exemplary embodiment of a grommet or eyelet (3) witha locking mechanism that prevents the mesh arm from backing out of themesh body, after insertion through the eyelet. The needle with attachedsuture, plastic dilator and part of the mesh strip is inserted throughthe eyelet. The amount of the mesh strip that is inserted through theeyelet may be variable, as it is a function of the circumference of thecervix. The mechanism has a “back-pack”-like strap adjuster, in thatthere are a plurality (e.g. two illustrated) elongated slots (e.g.fenestrations) (20) through which the mesh cerclage (1) is placed, andin the base or central bar (21) between the fenestrations there aredownwards-facing multiple stiff projections (22), in which the meshcerclage gets caught, preventing slippage of the mesh cerclage.

FIG. 18 depicts a cross-sectional view of the mechanism described inFIG. 17, with the “back-pack”-like strap adjuster, with the twoelongated slots (e.g. fenestrations) (20), the central base bar (21)with the downwards-facing multiple stiff projections (22), in which themesh cerclage (1) gets caught, preventing slippage of the mesh cerclage.The projections (22) are angled to permit insertion of the mesh, butwill snag or engage the mesh (1) in the event a force is applied toattempt to remove the mesh from the slots (20).

FIG. 19 depicts a mechanism on one end of the cerclage mesh strap (1)that has a slot (e.g. fenestration) (20), through which the other end ofthe mesh cerclage is inserted (after passing around the circumference ofthe cervix as a cerclage), and has a flap valve mechanism (23) with ajagged or “toothed” edge (24), in which the mesh cerclage material (1)is caught.

FIG. 20 depicts an exemplary embodiment of the medical device in which acentral cerclage portion of an elongated mesh strip is used to form acerclage around the cervix (e.g. at the cervical isthmus). The strip hasa width extending from a first side to a laterally opposed second side.Thereafter the proximal and distal ends (30, 32) of the mesh, peripheralto the cerclage portion, are coupled together. The mesh ends (30, 32)are arranged adjacent to each other and coupled together by a variety oftechniques, including stitching, clips (e.g. as shown in FIGS. 21-23),heat, glue, hook-and-loop fasteners, interrupted or continuous sutures,or other fastener(s) (40). The mesh ends may be coupled side-to-side,such that when they lie flat, they create a flat sacral portion having awidth equal to the combined widths of the proximal and distal ends. Theproximal and distal ends typically are joined first side to first sideor second side to second side, though the first side of one end may bejoined to the second side of the other end. This joining increases thesize of the mesh available for sacral securement. The coupled mesh ends(30,32) are then attached to the sacrum. The mesh can be formed with auniform width and thickness. Alternatively, the mesh can be formed withan increased width and/or thickness along the portion that forms thecerclage to locally increase the surface area and strength. The proximaland distal strip ends also may be coupled to another piece of mesh whichis itself sacrally secured.

FIGS. 21-23 show three views of a clip-type connector. Two plates withgripping teeth are joined to one another by a hinge joint. A male snapand a female receptacle are disposed in complementary positions on therespective plates.

FIG. 24 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle (31) attached to one end of a meshstrip (32) with a folded over segment of the mesh in the other end ofthe mesh strip (33) with some form of fixation (34) to hold the meshsegment together, such as suture, ultrasonic welding or some othermethod of attachment of mesh to mesh.

FIG. 25 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle (31) attached to one end of a meshstrip (32) with a narrower folded over segment of the mesh on the otherend of the mesh strip (35) with some form of fixation (34) to hold themesh segment together, such as suture, ultrasonic welding, or some othersuitable method of attaching mesh to mesh.

FIG. 26 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle (31) attached to one end of a meshstrip (32) with a loop at the other end (36), created by a permanentsuture attached to the end of the mesh. This may be a permanent suturematerial, such as polypropylene, and may be ultrasonically welded to theend of the mesh (37), or may be threaded through the end of the mesh andsuture as a loop.

FIG. 27 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle (31) swaged on to a loop of suturematerial (38), which is attached to the end of a mesh segment (32) byeither threading it through the mesh, ultrasonically welding it to themesh, or some other mechanism of attachment. There is a second permanentsuture loop (36) on the same end of the mesh, which is also attached tothe mesh by threading it through the mesh, ultrasonically welding it tothe mesh (37), or some other mechanism of attachment. Once the cerclageis complete, the suture swaged on to the needle is cut, leaving theother loop attached, and the other end of the mesh strip, which may bewider than the end of the mesh with the suture loops attached (40), isbrought through the loop and then attached to the sacrum, afterdetermining the proper tension.

FIG. 28 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle (31) swaged on to a suture loop(38), which is interlocked with another suture loop made of permanentsuture (36), which is either threaded through, ultrasonically welded(37), or otherwise attached to the end of the mesh strip (32). Once thecerclage is complete, the suture swaged on to the needle is cut, leavingthe other loop attached, and the other end of the mesh strip is broughtthrough the loop and then attached to the sacrum, after determining theproper tension.

FIG. 29 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle (31) swaged on to a suture loop(38), which is interlocked with another suture loop made of permanentsuture (36), which is either threaded through, ultrasonically welded(37), or otherwise attached to the narrow segment of the mesh strip(39), which may come in various lengths. The narrow mesh strip may thentransition to a wider mesh strip (40) for the remainder of the length ofthe mesh strip. Once the cerclage is complete, the suture swaged on tothe needle is cut, leaving the other loop attached, and the wider end ofthe mesh strip is brought through the loop and then attached to thesacrum, after determining the proper tension.

FIG. 30 illustrates an exemplary medical device in accordance with oneor more embodiments having a needle (31) swaged on to a narrow meshstrip (39), which is then attached to a narrow loop of the mesh strip(41), which is then attached to another thin strip of mesh (39), whichmay come in various lengths. The narrow mesh strip may then transitionto a wider mesh strip (40) for the remainder of the length of the meshstrip. Once the cerclage is complete, the thin mesh strip swaged on tothe needle is cut, leaving the mesh loop attached, and the wider end ofthe mesh strip is brought through the mesh loop and then attached to thesacrum, after determining the proper tension.

FIG. 31 demonstrates a sagittal view of the pelvis with an exemplarydevice in accordance with one or more embodiments in place around thecervix (43), near the junction with the uterus (42). After placement ofthe mesh strip (32) of the device around the cervix, the loop in themesh (33) remains posterior to the cervix and the other end of the meshstrip (32) passes through the loop and is attached to the sacralpromontory (44).

In addition to the specific embodiments claimed below, the disclosedsubject matter is also directed to other embodiments having any otherpossible combination of the dependent features claimed below and thosedisclosed above. As such, the particular features presented in thedependent claims and disclosed above can be combined with each other inother manners within the scope of the disclosed subject matter such thatthe disclosed subject matter should be recognized as also specificallydirected to other embodiments having any other possible combinations.Thus, the foregoing description of specific embodiments of the disclosedsubject matter has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit thedisclosed subject matter to those embodiments disclosed. As noted above,reference to “mesh” is to be taken as a reference to other flat,flexible materials in the alternative or in combination.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the method and system of thedisclosed subject matter without departing from the spirit or scope ofthe disclosed subject matter. Thus, it is intended that the disclosedsubject matter include modifications and variations that are within thescope of the appended claims and their equivalents.

What is claimed is:
 1. An implantable cerclage sacrocolpopexy medicaldevice, comprising: an elongate strip of flat, flexible materialextending longitudinally from a first end to an opposite second end; asurgical needle attached to the first end of the elongate strip; and aloop at either: (1) the first end of the elongate strip proximate theneedle, wherein the loop is sized and shaped to enable passagetherethrough of the second end of the elongate strip after the elongatestrip has been positioned to encircle the cervix in a cerclageconfiguration and the needle has been detached from the elongate strip,and wherein the second end of the elongate strip is configured forattachment to the sacrum or sacrospinous ligament, or (2) the second endof the elongate strip, wherein the loop is sized and shaped to enablepassage therethrough of the first end of the elongate strip after theelongate strip has been positioned to encircle the cervix in a cerclageconfiguration and the needle has been detached from the elongate strip,and wherein the first end of the elongate strip is configured forattachment to the sacrum or sacrospinous ligament.
 2. The medical deviceof claim 1, wherein the flat, flexible material comprises a meshmaterial.
 3. The medical device of claim 1, wherein the flat, flexiblematerial comprises a fabric or a non-cross-linked biologic graft.
 4. Themedical device of claim 1, wherein the needle is either straight orcurved, and either sharp or blunt-tipped.
 5. The medical device of claim1, wherein the surgical needle is swaged to the first end of theelongate strip.
 6. The medical device of claim 5, further comprising asleeve covering an area of the device where the needle is swaged to thefirst end of the elongate strip to reduce resistance when the device ismoved through cervical tissue.
 7. The medical device of claim 1, whereinthe loop is formed from a portion of the elongate strip folded over andaffixed to itself.
 8. The medical device of claim 7, wherein the portionof the elongate strip is affixed to itself using suturing or ultrasonicwelding.
 9. The medical device of claim 1, wherein the elongate strip istapered proximate the loop.
 10. The medical device of claim 1, whereinthe surgical needle is swaged onto a suture loop attached to the firstend of the elongate strip.
 11. The medical device of claim 1, whereinthe loop is at the second end of the elongate strip, and wherein theloop is formed from a suture attached to the second end of the elongatestrip.
 12. The medical device of claim 1, wherein the loop is at thefirst end of the elongate strip, and wherein the loop is formed from asuture attached to the first end of the elongate strip.
 13. The medicaldevice of claim 12, wherein the surgical needle is attached to the firstend of the elongate strip using another suture.
 14. The medical deviceof claim 12, wherein the surgical needle is attached to the loop usinganother suture forming another loop interlocked with the loop.
 15. Themedical device of claim 12, wherein the second end of the elongate stripis wider than the first end of the elongate strip.
 16. A method oftreating prolapse in a patient, comprising: (a) positioning animplantable cerclage sacrocolpopexy medical device circumferentiallyaround the cervix of the patient, said medical device comprising anelongate strip of flat, flexible material extending longitudinally froma first end to an opposite second end, a surgical needle attached to thefirst end of the elongate strip, and a loop at either the first end orthe second end; (b) detaching the surgical needle from the medicaldevice and removing the surgical needle from the operative field; (c)passing the end of the elongate strip opposite the end having the loopthrough the loop; and (d) attaching the end of the elongate strip passedthrough the loop to the sacrum or sacrospinous ligament of the patient.17. The method of claim 16, further comprising applying a suitabletension in the elongate strip prior to step (d).
 18. The method of claim16, wherein step (d) comprises suturing the elongate strip or applyingsurgical tacks to the elongate strip.